Granisetron EP Impurity C(Hydrochloride) NEW

Granisetron EP Impurity C(Hydrochloride)

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E-mail: anna@molcoo.com.

• Product Information

• Product Number: G006010A

• English Name: Granisetron EP Impurity C(Hydrochloride)

• English Alias: N-((1R,3r,5S)-9-azabicyclo[3.3.1]nonan-3-yl)-1-methyl-1H-indazole-3-carboxamide hydrochloride

• CAS Number: None

• Molecular Formula: C₁₇H₂₂N₄O·HCl

• Molecular Weight: 334.84（298.38 + 36.46）

• Advantages

• As an EP hydrochloride impurity reference standard for granisetron, this compound has the following advantages:
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• Well-defined structure and stable salt form: Precise indazole amide and bicyclic amine structure, combined with the stability of hydrochloride, enabling analysis of by-product formation mechanisms during granisetron synthesis, such as indazole ring construction, amination, and salification reactions, to optimize processes for impurity control;

• Polycyclic structure standard substance: Complex structure with indazole ring, azabicyclononane, and amide group provides an accurate standard for HPLC, LC-MS, and other detection methods to improve separation and quantification accuracy of granisetron-related impurities;

• Water solubility advantage: The hydrochloride form enhances the compound's water solubility, facilitating simulation of impurity behavior in physiological environments during formulation stability studies and impurity detection.

• Applications

• Drug Development: Used as an impurity reference standard to identify and quantify Impurity C in granisetron and its formulations, evaluating the purity of APIs and formulations;

• Quality Control: Acting as a standard substance to validate the sensitivity and specificity of detection methods (e.g., HPLC, LC-MS), ensuring impurity content meets European Pharmacopoeia (EP) requirements during production;

• Stability Studies: Investigating the degradation behavior of this impurity under light, high temperature, and high humidity conditions to evaluate its impact on granisetron formulation stability and assist in determining storage conditions.

• Background Description

• Granisetron is a 5-hydroxytryptamine receptor antagonist used for preventing and treating chemotherapy-induced nausea and vomiting. During its synthesis, incomplete indazole ring substitution reactions or improper control of amination reaction conditions easily generate impurities containing azabicyclic structures. As a key quality-controlled impurity in granisetron EP standards, research on this hydrochloride impurity is an important part of ensuring drug safety and effectiveness.

• Research Status

• Current research focuses on:
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• Detection method optimization: Establishing trace detection methods (detection limits reach ppb level) using UPLC-MS/MS technology, enhancing mass spectrometry response by leveraging the ionization characteristics of hydrochloride;

• Synthesis process improvement: Reducing by-product generation by optimizing the nitration temperature of the indazole ring and the catalyst (such as triethylamine) for the amination reaction;

• Salt form stability: Studying the hygroscopicity and degradation pathways of hydrochloride under high humidity conditions to provide data for storage conditions;

• Toxicological evaluation: Evaluating the potential affinity and safety of this impurity for 5-hydroxytryptamine receptors through in vitro cytotoxicity experiments

This product is intended for laboratory use only!

WhatsAPP: +86 17386083646
E-mail: anna@molcoo.com